Author： Foged Niels T Brügmann Anja Jørgensen Jan T
Publisher： Informa Healthcare
ISSN： 1473-7159
Source： Expert Review of Molecular Diagnostics, Vol.13, Iss.3, 2013-04, pp. : 233-242
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Abstract
Testing for amplification of the human EGF receptor 2 (HER2) gene by in situ hybridization is a central principle for the identification of breast cancer patients likely to respond to treatments directed toward HER2. However, its application in clinical routine has been somewhat restricted by the typical use of a visualization system based on fluorescence (FISH), which requires skilled, work-intensive, high-magnification quantitative microscopy. The US FDA has recently approved the HER2 CISH pharmDx™ Kit, which is characterized by employing a chromogenic visualization system that allows quantification of the HER2 gene and centromere 17 reference signals by relatively low-magnification brightfield microscopy. It is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered.
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